MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number UNK-CV-SR-VALIANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942); Pain (1994); Paralysis (1997); Renal Failure (2041); Numbness (2415); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 04/05/2017

Event Type  Injury  

Event Description

Valiant stent grafts (22x100mm) was implanted during the emergent tevar treatment of a blunt thoracic aortic injury (btai) with transection distal to the left subclavian artery origin on an unknown date.The injury was noted as 40mm long beginning 10mm distal to the lsca.The aortic diameter was noted as 22mm just distal to the lca and 18mm in the mid descending aorta.It was reported approximately 9 months post the index procedure the patient presented with sudden painful paresthesia below the waist and swelling of the left foot and began experiencing chest pain 3 days after onset of symptoms.It was reported the patient collapsed and was transferred to hospital.Decreased motor function and sensation were noted in the bilateral lower extremities.Ct demonstrated near occlusive thrombosis within the distal portion of the thoracic stent.Heparin therapy was commenced.The patient developed renal failure and abdominal pain with lower gastrointestinal bleeding.No obvious structural defects of the endografts including stent collapse, migration or gross infolding were seen.A right axillofemoral bypass was performed for the lower extremity ischemia.Post op the patients biphasic pules returned in the bilateral extremities, neurological function returned to baseline and bowel and renal injury resolved after 3 days of hemodialysis.Per the physician the cause of the adverse events are undetermined.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Medtronic received the following information from a journal article entitled;safety and durability of single-stage type i hybrid total aortic arch repair for extensive aortic arch disease: symptomatic intragraft thrombus following endovascular repair of blunt thoracic aortic injury abdoli et al, annals of vascular surgery (42) 305.27-305.E12 https://doi.Org/10.1016/j.Avsg.2016.12.007.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13289201
• MDR Text Key: 284014564
• Report Number: 9612164-2022-00270
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-VALIANT
• Device Catalogue Number: UNK-CV-SR-VALIANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 01/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR